FDA Device recall Z-2391-2025
S4-1 Transducer Probe
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of S4-1 Transducer Probe by Philips Ultrasound, citing to provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2391-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-07-03 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Ultrasound |
| Distribution | US |
Product
S4-1 Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Identifiers
| code_info | Model No. 989605389271, 989605389272, 989605364993; UDI: (01)00884838061415(21)B30VBN, (01)00884838061415(21)F0954W, (0…Model No. 989605389271, 989605389272, 989605364993; UDI: (01)00884838061415(21)B30VBN, (01)00884838061415(21)F0954W, (01)00884838061415(21)B3WCRT, (01)00884838061415(21)B1WDKX, (01)00884838061415(21)B1WDNQ, (01)00884838064584(21)B13HXX, (01)00884838064584(21)B1MQDX, (01)00884838064584(21)B23LRM, (01)00884838064584(21)B23LRT, (01)00884838061415(21)B1X9Z3, (01)00884838064584(21)B12QQ8, (01)00884838061415(21)B27XB2, (01)00884838061415(21)B307TT, 010088483806141521F01WFB, (01)00884838061415(21)B30THD, (01)00884838061415(21)B1TKB3, (01)00884838061415(21)F08XDL, (01)00884838061415(21)F0B7L5, (01)00884838061415(21)F048QQ, (01)00884838061415(21)F0665R; Serial No. B30VBN, B1GPT4, B1NW75, F0954W, B3WCRT, B1WDKX, B1WDNQ, B13HXX, B1MQDX, B23LRM, B23LRT, B1X9Z3, B12QQ8, B27XB2, B307TT, F01WFB, B1KXRP, B30THD, B1TKB3, F08XDL, F0B7L5, F048QQ, F0665R. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2391-2025%22
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